In a new study published in the Annals of Internal Medicine, researchers found that overweight and obese patients who used a popular smart phone app (MyFitnessPal) did not lose significant weight after a 6 month trial period. The randomized controlled trial is the first of its kind to demonstrate that well-liked mobile apps may be ineffective for most users.

Two hundred and twelve racially diverse (73% female) patients treated at two UCLA primary care clinics were enrolled in the study. All indicated that they were interested in losing weight and 79% who completed the study indicated that they were “somewhat” or “completely” satisfied with the app, while 92% reported that they’d recommend it to a friend.

Unfortunately, as pleased as the subjects were with the app, there was no statistically significant difference in weight loss between the intervention and control groups. On average, the MyFitnessPal users lost 0.66 lbs in 6 months.

The authors note:

“Most participants rarely used the app after the first month of the study… Given these results it may not be worth a clinician’s time to prescribe MyFitnessPal to every overweight patient with a smart phone… Our analysis did not show any demographic covariates to be important predictors of app use.”

This study serves as a reminder that “popular” and “effective” do not always go hand-in-hand when it comes to weight loss interventions. While mHealth apps are expected to earn $26 billion by 2017, one is left to wonder if this money will be well spent or if we’ll all be “somewhat to completely satisfied” with the apps without anything medically significant to show for it?

The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions. Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.

These conflicting motives create a disconnect in the minds and behaviors of many people. They pay lip service to science-based medicine, but are good at making juicy rationalizations to justify what they want to be true rather than what the science supports. We all do this to some degree – but, in my opinion, complementary and alternative medicine (CAM) is a cultural institution that is built upon these rationalizations. It is formalized illogic and anti-science conceals as science under a mountain of rationalizations.

The British Medical Journal (BMJ) recently published a review of acupuncture studies in the treatment of chronic pain. Like most other reviews of acupuncture studies, the authors were not impressed. They concluded:

A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

After decades of study and hundred of clinical trials, this remains the state of acupuncture research. The best studies continue to show an unclear effect, which cannot be separated from bias – which of course is the point of clinical trials. In other words, the signal cannot be separated from the noise. The most parsimonious interpretation of this fact is that there is no significant signal – acupuncture does not work.

But supporters of acupuncture prefer to go through a litany of rationalizations rather than acknowledge that simple fact (more on this later).

It was also recently announced that the BMJ group will be adding a new journal: BMJ Acupuncture. That’s right, an entire journal dedicated to studying (read “promoting”) acupuncture. The press release notes:

Acupuncture in Medicine is a quarterly title, which aims to build the evidence base for acupuncture.

I thought the purpose of research was to discover if a treatment works, not to build a case for it.

BMJ is a strange journal – it is generally of high quality but seems to have a blind spot for certain CAM modalities, like acupuncture. While it will publish critical reviews, like the one above, it also has published some low quality positive reviews – such as this one of acupuncture and IVF (in vitro fertilization). The review glosses over the disparity in study quality and location. Other reviews published around the same time showed no effect from acupuncture in IVF.

And the best individual studies to date show no effect. In fact, the most recent study showed that the placebo acupuncture group had slightly higher pregnancy rates by some measures than the acupuncture group (while other measures showed no difference). Again – the most parsimonious interpretation of this study is the null hypothesis – acupuncture does not work in IVF. But proponents twisted themselves into logical pretzels and offered up the astounding rationalization that placebo acupuncture must have some real effect.

To be clear, I am not against journals that specialize in one area, or practitioners that specialize in one form of treatment. Specialization is essential to deal with the modern complexity of medicine. However, we must recognize the significant risk of specialization – and that is the fallacy that is often summarized as follows: if your only tool is a hammer then every problem will look like a nail. It is unlikely that a journal or practitioner dedicated to acupuncture will ever reach the conclusion that acupuncture is a dead end and science-based medicine should move on. As an extension of this, specialty journals and specialist should follow well-established modalities. Forming a specialty journal dedicated to an unproven and dubious modality is problematic, to say the least.

More Rationalizations

A recent Washington Post article observes in its headline: “Millions embrace acupuncture, despite thin evidence.” It seems this reporter, Ellen Edwards, has grasped the essential disconnect, although she does not sufficiently explore an answer to the implied question – why? Why do so many accept acupuncture despite an enduring absence of scientific evidence? Ironically, the press has much to do with it. They are often complicit in misrepresenting the facts, and abetting the rationalizations that are necessary for those who should know better to continue to promote acupuncture despite the lack of evidence.

Some professional organizations are also complicit. The article notes, for example:

The American Medical Association takes no position specifically on acupuncture; the AMA groups it with other alternative treatments, saying “there is little evidence to confirm the safety or efficacy of most alternative therapies.” It says “well-designed, stringently controlled research” is needed to evaluate its efficacy.

Now, the AMA is not the best place to go for position papers on specific scientific questions in medicine. But if they are going to bother having any position, it should be better informed. They say that research is needed, giving the impression that there isn’t already a large body of research to inform out opinion about whether acupuncture works or not.

The notion that more research is needed is one of the most common rationalizations. That allows someone to put off forever concluding that their pet modality does not work – simply make the case for more research, which is easy to make sound like it’s a good idea. And of course anyone against more research must be closed-minded. For example, the story relates (standard disclaimer – I am aware that experts are often quoted out of context by journalists, so keep that in mind, but for the purposes of this post I will take the quotes at face value):

In 2007, NCCAM spent about $9.1 million on acupuncture research. While more is planned, Brent Bauer, an internist at the Mayo Clinic and director of its complementary and alternative medicine program, said the research is in its “toddlerhood.”

Nice touch – “toddlerhood.” That’s just a cute way of saying that more research is needed and you can comfortably ignore any current negative research. If the assessment were fair, then it could be justified. But we have already had several fairly sophisticated placebo-acupuncture controlled trials. This represents reasonably mature clinical research. I suspect
Bauer just does not like the fact that these best studies (like the IVF study above) are generally negative. I wonder – if these studies were positive would he still think they were imature and could be ignored?

Linda Lee, a gastroenterologist who is director of Johns Hopkins’s new Integrative Medicine and Digestive Center, is quoted as saying:

“We have this double standard. We are completely comfortable using pharmacological therapies that have not been subjected to clinical trials for the purposes we use them, but we are super suspicious of alternative therapies that haven’t been tested with randomized placebo trials. From a research point of view, I understand the criticism. But we physicians are in the healing business, and we have to go beyond the pharmacological solutions to understand the whole person,” she said. “Acupuncturists start with the whole person.”

Ah – the “holistic” gambit. This is just another rationalization to distract people from the uncomfortable fact, that she acknowledged. From a “research point of view” means “I understand that the best quality scientific evidence is negative.” And “we..are in the healing business” means “but I want to believe in this anyway.”

The double standard is also an incredible claim, because the opposite is true. SBM advocates want a single standard. What Dr. Lee is actually referring to is prior plausibility – scientific practitioners are more accepting of treatments that are biologically plausible, and are appropriately skeptical of treatments that are extremely implausible. It is also a tu quoque fallacy – we advocate high standards of science for all treatments, even plausible ones. If some doctors uses drugs unscientifically, that does not justify chucking science whenever it conflicts with our beliefs and desires.

It is, in fact, the CAM proponents who want a double standard. Imagine if after hundreds of studies the best a drug could do for any indication is a weak effect that is likely just placebo – the signal cannot be separated from the noise. Imagine a pharmaceutical company making the exact same rationalizations to put its failed drug on the market anyway that acupuncture proponents make for acupuncture.

The article concludes, as most do, with a positive anecdote from a believer – Elise Feingold:

“I decided to leave my science brain aside,” she said. “I felt it had helped other people, and it might help me. I don’t know how it works, but it’s got 4,000 years of Chinese medicine behind it.”

She begins with what amounts to saying that anecdotal evidence is more compelling that rigorous science. This, of course, makes no sense. The whole point of scientific rigor is for evidence to be more objective and reliable – to control for any many variables as possible. Anecdotes are unreliable because they do not control for any variables. Proponents of acupuncture are happy to cite scientific evidence when they think it supports their beliefs, but then will chuck science in favor of low quality anecdotes as needed.

Feingold finishes with the commonplace appeal to antiquity. The premise of this argument is that a treatment that has no real effect could not survive for thousands of years. History proves that this premise is false (see blood letting), and it also profoundly underestimates the human capacity for self-deception and therefore the need for scientific controls.

Conclusion

There is still no compelling evidence that there is any real effect to acupuncture. It didn’t have to turn out that way, but that is the way the scientific chips fell. The treatment also lacks plausibility (although I usually point out that something is happening, unlike homeopathy, and so there is the physical possibility of an effect), and in medicine you only get two strikes. No evidence and no plausibility means that you’re out.

But the disconnect continues. Proponents keep pretending that there is compelling evidence, or it has not been properly studied yet, or it does not have to be studied because historical anecdotes are enough – whichever argument suits the moment. Meanwhile the media keep breathlessly telling us that acupuncture is gaining ground, while the evidence is standing still.

The premise of SBM is that support and resources should follow scientific support. In the world of CAM, however, support follows belief, and the science seems to be an afterthought or, worse, an obstacle.

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